Health Products Regulatory Authority Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Dalmapam 15mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flurazepam (as flurazepam monohydrochloride) 15 mg Each capsule also contains 159.1mg of lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Size 3, ivory / light grey hard gelatin capsules, marked ‘Flu 15 ’ 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Insomnia Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 Posology and method of administration Insomnia Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including tapering off process of four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without reevaluation of the patient ’s status. Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. Adults: The usual dosage is 15 -30mg before retiring. 15mg is optimal for most patients. Patients with severe insomnia may require 30mg but residual effects on awakening, associated with an anxiolytic effects, are more frequent at this dose. Older or debilitated patients: Older patients will be particularly susceptible to the adverse effects of Dalmapam. The initial dose should not exceed 15mg. If organic brain changes are present, the dosage of Dalmapam should be reduced (see section 4.4). Use in patients with hepatic and renal impairment: The dosage should be reduced in patients with renal or hepatic impairment. Dalmapam is contraindicated in patients with severe hepatic failure (see sections 4.3 and 4.4). Use in patients with chronic pulmonary insufficiency: In patients with chronic pulmonary insufficiency the dosage may need to be reduced. Children: Not recommended. ______________________________________________________________________________________________________________________ Date Printed 23/05/2017 CRN 2187917 page number: 1 Health Products Regulatory Authority Method of administration Oral use. The product should be taken just before going to bed. The patient should be checked regularly at the start of the treatment in order to decrease if necessary, the dose or frequency of administration to prevent overdose due to accumulation. 4.3 Contraindications Patients with hypersensitivity to flurazepam, other benzodiazepines, or to any of the excipients listed in section 6.1; Myasthenia gravis Severe pulmonary insufficiency Severe respiratory insufficiency Sleep apnoea syndrome Severe hepatic insufficiency Phobic or obsessional states Chronic psychosis 4.4 Special warnings and precautions for use Dalmapam should not be used alone to treat depression or anxiety associated with depression since suicide may be precipitated in such patients. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Benzodiazepines are not recommended for the primary treatment of psychotic illness. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Dalmapam is not indicated in patients with spinal and cerebellar ataxia. Dalmapam should not be given in acute intoxication with alcohol, sedative agents, hypnotic agents, analgesics or psychotropic agents (neuroleptic agents, antidepressants, lithium). Dalmapam is not indicated for children. If necessary for compelling reasons, benzodiazepines should be prescribed for children and adolescents after careful appraisal of the risk -benefit ratio. Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Lactose intolerance Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose -galactose malabsorption should not take this medicine. Dependence Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia, irritability, sweating, diarrhea, headaches and muscle pain has been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time. ______________________________________________________________________________________________________________________ Date Printed 23/05/2017 CRN 2187917 page number: 2 Health Products Regulatory Authority In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. In rare instances, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions. Abuse of benzodiazepines has been reported. Rebound insomnia and anxiety This is a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Duration of treatment The duration of treatment should be as short as possible (see 4.2, Posology and method of Administration), depending on the indication,but should not exceed 4 weeks including tapering off process. Extension beyond these periods should not take place without reevaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should that occur while the medicinal product is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also section 4.8, Undesirable Effects). If the patient is awoken during the period of maximum drug activity, recall may be impaired. Psychiatric and ‘paradoxical ’ reactions Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioural effects included paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and the uncovering of depression with suicidal tendencies. If any of these reactions occur, use of the drug should be discontinued. These reactions may be quite severe and more likely to occur in children and older patients. Specific patient groups Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Older patients should be given reduced dose (see section 4.2, Posology and Method of Administration). Due to myorelaxant effect of Dalmapam there is a risk of falls and consequently of hip fractures particularly for older patients when they get up at night. A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy and reduced doses should be given to patients with renal or hepatic disease. The dosage should be reduced in patients with organic brain changes. Benzodiazepines are not recommended for the primary treatment of psychotic illness. ______________________________________________________________________________________________________________________ Date Printed 23/05/2017 CRN 2187917 page number: 3 Health Products Regulatory Authority Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients). Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. 4.5 Interaction with other medicinal products and other forms of interaction Not recommended Concomitant intake with alcohol The sedative effect may be enhanced when the product is used in combination with alcohol. This adversely affects the ability to drive or use machines. Take into account Combination with